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1. Participant Information

Understanding barriers, facilitators and motivators to participation in clinical trials in Parkinson’s disease

You are being invited to take part in this survey-based research project. Before you decide whether or not to take part, it is important for you to understand why the research is being undertaken and what it will involve. Please take time to read the following information carefully and discuss it with others, if you wish.

Thank you for reading this.

1. What is the purpose of this research project?

This survey will ask questions about the barriers and motivating factors to participating in Parkinson’s clinical trials. We hope the data gathered will highlight how clinical trial teams can support participants before, during and after taking part in research. This survey has been written by Cardiff University in collaboration with Cure Parkinson’s (a registered AMRC charity) and the University of Plymouth. We are very grateful to the dedicated patient advocates who have helped to review and shape it.

2. Why have I been invited to take part?

This survey is open to all people with Parkinson’s (with the help of a care partner if preferred) whether they have or have not previously taken part in any kind of research.
 
3. Do I have to take part?
 
Your participation in this survey is entirely voluntary and it is up to you to decide whether or not to take part. If you decide not to take part, you do not have to explain your reasons and it will not affect your legal rights. You are free to stop and/ or not submit your answers at any time, without giving a reason.
 
4. What will taking part involve?
 
Should you decide to take part you will be directed to the main survey and asked if you have previously taken part in a Parkinson’s clinical trial. For the purposes of this survey we have defined Parkinson’s clinical trials as any of the following:
  • Interventional drug trials
  • Gene therapy trials
  • Cell therapy trials
  • Other neurosurgical interventions (e.g. GDNF, DBS)
Your answer to this (‘yes’ or ‘no’) will direct you to relevant set of questions. If you answered ‘yes’ you will be asked to complete 30 questions at most, with an option to answer up to 18 more. It will not affect your ability to submit previous answers if you decide not to answer these additional questions. We anticipate that this will take 35 or 45 minutes at most. If you answered ‘no’ you will be asked to complete up to 30 questions and we anticipate that this will take 35 minutes at most. A majority of these questions are multiple choice or yes/no answers, very few will require a text-based answer.

5. Will I be paid for taking part?

You should understand that any data you give will be as a gift and you will not benefit financially in the future should this research project lead to the development of a new treatment/method/test/assessment.
6. What are the possible benefits of taking part?

By completing this survey you will benefit the wider Parkinson’s community by improving our understanding of what factors stop or motivate people with Parkinson’s to participate in clinical trials. We hope to gather data to understand how we can improve the trial experience for participants and inform resources for participants to understand what to expect and what is expected of them throughout a trial. Furthermore we hope this will improve accessibility to trials and interventions, ensuring future clinical trial cohorts that better represent the population.

7. What are the possible risks of taking part?

We do not anticipate any risks to completing this survey.


8. Will my taking part in this research project be kept confidential?

All personal information collected about you during the research project will be kept confidential and managed in accordance with data protection legislation. Please see ‘What will happen to my Personal Data?’ (below) for further information. Other data collected may be shared and published in an anonymised form. We ask you to not include any information in the survey that may be identifiable.

9. What will happen to my personal data?

Cardiff University is the Data Controller for the survey data and is committed to respecting and protecting your personal data in accordance with your expectations and Data Protection legislation. Further information about Data Protection, including:

- your rights
- the legal basis under which Cardiff University processes your personal data for research
- Cardiff University’s Data Protection Policy
- how to contact the Cardiff University Data Protection Officer
- how to contact the Information Commissioner’s Office

may be found at https://www.cardiff.ac.uk/public-information/policies-and-procedures/data-protection


All data will be collected anonymously. At the end of the primary survey you are directed to a second survey where you are given the option to provide some personal details to be contacted with the results of the survey and further opportunities only. These details will be kept separate from any data gathered in the primary survey. Any identifiable information will be retained in accordance with the University Records Retention Schedules and may be accessed by members of the research team and, where necessary, by members of the University’s governance and audit teams or by regulatory authorities.

Cure Parkinson’s will be the data controller for the mailing list and all personal data will be managed in line with Cure Parkinson’s data privacy policy which can be found in the following link:

https://cureparkinsons.org.uk/privacy-policy/

Anonymised information will be kept for a minimum amount of time (5 years) by Cardiff University in accordance with the University Records Retention Schedules but may be published in support of the research project and/or retained indefinitely, where it is likely to have continuing value for research purposes.

Anonymised data will be shared with Cure Parkinson’s and the University of Plymouth. Cleaned, anonymous data, with any potentially identifying factors redacted, may be shared with third parties such as academic institutes, industry partners and funding bodies.
10. What happens to the data at the end of the research project?

After the end of the survey, personal data will be used in accordance with your preferences indicated in the survey. Anonymised data will be shared with University of Plymouth and Cure Parkinson’s according to the data management plan as previously detailed.

11. What will happen to the results of the research project?

Anonymised data will be analysed and initial findings submitted to present at Rallying to the Challenge 2022 and possibly World Parkinson’s Congress. Findings will also be submitted for publishing to Journal of Parkinson’s Disease. Participants will not be identified in any report, presentation or publication.

12. What if there is a problem?

If you wish to complain or have grounds for concern about any aspect of the manner in which you have been approached please contact Dr Emma Lane at LEARN@cardiff.ac.uk. If your complaint is not managed to your satisfaction, please contact Pharmacy Research Office phrmyresoffice@cardiff.ac.uk

13. Who is organising and funding this research project?

This survey has been produced by Cardiff University in collaboration with Plymouth University and Cure Parkinson’s, who are funding this research.

14. Who has reviewed this research project?

This survey has been reviewed and given favourable opinion by Cardiff University School of Pharmacy School Research Ethics Committee. It was also reviewed by a group of Parkinson’s patient advocates.

15. Further information and contact details.

Should you have any questions relating to this research project you may reach us during normal working hours: LEARN@cardiff.ac.uk

Thank you for considering taking this survey.


By clicking ‘next’ you are agreeing to take the survey.


 

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